1. Field of the Invention
The present invention relates to a crystal of morphinan derivative, a manufacturing method thereof, and a pharmaceutical composition using the same, and more particularly to a crystal of morphinan derivative prepared using a hydrogen chloride organic solution, a manufacturing method thereof, and a pharmaceutical composition using the same.
2. Description of Related Art
In general, in the medical field, compounds of different crystal forms may have different physical properties such as solubility, dissolution rate, stability, absorption, etc. Therefore, even for a given compound, the potency may vary with its crystal form. Thus, it is desirable to provide a compound having stable physical properties.
17-cyclopropylmethyl-3,14β-dihydroxy-4,5α-epoxy-6β-[N-methyl-trans-3-(3-furyl)acrylamido]morphinan hydrochloride has been confirmed as an effective active ingredient of analgesic, diuretic and antipruritic agents. U.S. Pat. No. 7,803,942 B2 discloses that the morphinan derivatives have A, B, and C crystal forms. However, its preparation processes are cumbersome, lengthy, and yet require the corresponding seed crystals to prepare the above-mentioned crystals. Furthermore, although the conventional crystal of morphinan derivative has a lower pH variation than its amorphous form, the improvement is still unsatisfactory.
Therefore, in order to optimize the physical properties of the morphinan derivative as well as to simplify the preparation processes of its crystals, it is needed to provide a novel crystal of morphinan derivative and a manufacturing method thereof.